1. Field of the Invention
The present invention relates to a novel composition useful as a replacement for steroids as a muscle growth stimulant and for stimulating an immune response, and to the use thereof.
2. Description of the Prior Art
The problems of maintaining muscle mass while minimizing the accumulation of fat has long been an issue of concern to athletes. While exercise is one of the main mechanisms for achieving that goal, food and/or vitamin supplements, as well as pituitary growth hormone, are necessary for muscle growth. Such ergogenic aids, that is supplements which stimulate muscle growth, include the three amino acids, leucine, isoleucine and valine. Human Growth Hormone (HGH) has also been considered. Zale, N., xe2x80x9cAmino Acidsxe2x80x94Growth Hormone Stimulants Fact or Fiction?xe2x80x9d, Iron Man Magazine, Jan. 1985 and New England Journal of Medicine (1990). Growth hormone produces an anabolic effect which includes the process of converting amino acids into protein. The cost of using human growth hormone is very high. Thus, economic reality generally detracts from its use.
Likewise, the use of steroids to improve performance and increase muscle mass is fraught with disadvantages. Anabolic steroids have undesirable side effects which are linked to a variety of serious health problems including cardiovascular disease and liver cancer.
Chemical compounds have also been found to be important not for their direct influence on muscle growth, but rather as complements to or synergists for other compounds which stimulate muscle growth. Boron is one such compound. Boron is an essential mineral which is believed to play an important role in the retention of calcium. Likewise, chromium has been found to be a beneficial supplement for athletes. It has been speculated that chromium losses are twice as high on a workout day versus a non-workout day.
In addition, trans-ferulic acid, which is the metabolically active form of gamma oryzanol, is believed to increase the production of key brain chemicals thereby causing increased secretion of growth hormone.
In spite of the extensive studies and research to date, there remains a long-felt need in the art for a safe and effective method of stimulating muscle growth and taking the place of steroids, especially for athletes.
Surprisingly, the present inventor has now found that the laevorotatory form of arginine (L-arginine) is useful as a muscle stimulant in a mammalian organism, especially a human, when preferably present in a formulation which contains the proper adjuvants and/or synergists. More particularly, it has been found that therapeutic doages of L-arginine, typically up to 15 g per day, can be rendered more palatable to a patient (L-arginine has an extremely unpleasant taste) and are better physiologically tolerated by a patient (reduced incidence of diarrhea, headache, flatulence, and depletion of vitamins and electrolytes) by careful control of the pH of the formulation so as to be less than 7, i.e. an acid pH. As a result, long term therapy.with L-arginine with reduced side-effects is obtained, in particular reduced depletion of acetyl choline from the brain and consequential reduced.incidence of memory loss.
In one aspect, the present invention provides a composition comprising L-arginine in a form which is palatable to a patient, physiologically tolerated and suitable for enhancing muscle growth, body fat reduction and stimulation of growth hormone in a mammalian organism, in association with a pH control agent for controling the pH of the composition at less than 7, preferably less than 6.0, for example about 3.5 to 5.5, especially 4.5 to 4.7, and an pharmaceutically acceptable carrier.
More particularly, the present invention provides a composition or complex comprising L-arginine, L-leucine, L-isoleucine, L-valine, boron (or sodium borate), vitamin B5 (calcium pantothenate), chromium, trans ferulic acid, gamma oryzanol, choline, fructose, lemon, lime and citric acid, in which the ratio of components is such that the pH of the composition is less than 7.0, preferably less than 6.0, more preferably 4.5 to 4.7. The composition suitably allows enhanced muscle growth with minimum side effects, especially over extended therapy periods, for example 4 to 8 weeks.
In another aspect, the invention provides a method for stimulating muscle growth in a mammalian organism comprising the step of administering to a host a muscle growth stimulant or enhancing effective amount of an L-arginine formulation comprising L-arginine or a salt thereof in association with a pH control agent for controling the pH of the formulation at less than 7 and an adjuvant suitable for stimulating muscle growth.
In yet another aspect, there is provided a method of stumulating an immune response in a patient in need of such treatment, comprising the step of administering to that patient an effective amount of an L-arginine formulation in association with a suitable adjuvant and/or diluent. Preferably, the L-arginine is administered intravenously as an aqueous solution in an amount of 1-10 g per day. More preferably, the L-arginine is co-administered with an immune system stimulator which is preferably vitamin C, in an amount of 1-10 g per day.
Other objects and advantages of the present invention will be apparent from the following description.